Drugs in ATC Class H04A

Up to Top Level ATC Classes

Up to H - Systemic hormonal preparations, excluding sex hormones and insulins

Up to H04 - PANCREATIC HORMONES

Subclasses in ATC: H04A - GLYCOGENOLYTIC HORMONES

H04AA - Glycogenolytic hormones

H04A Market Analysis and Financial Projection

The ATC Class H04A (Glycogenolytic Hormones) primarily encompasses glucagon-based therapies critical for managing severe hypoglycemia and gastrointestinal diagnostics. Here's an analysis of its market dynamics and patent landscape:

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Market Dynamics

Growth Drivers

• Rising Diabetes Prevalence: With global diabetes cases doubling since 1980 (reaching 529M in 2021), demand for glucagon as an emergency hypoglycemia treatment has surged[1][14]. The World Health Organization predicts 1.3B cases by 2050, further bolstering market growth[14].
• Innovative Delivery Systems: Transition from traditional injectables to nasal sprays (e.g., Baqsimi) and auto-injectors (e.g., Zegalogue) has improved accessibility. These products account for ~30% of recent market expansion[11][12].
• Reimbursement Policies: In the U.S., ~78% of insured patients have coverage for glucagon therapies like Gvoke HypoPen, enhancing affordability[14].

Market Projections

• Valuation: The market grew from $576M (2024) to a projected $1.1B by 2033, at a 5.9% CAGR[11][13].
• Regional Dominance: North America holds 34.5% market share ($214.3M in 2023), driven by advanced healthcare infrastructure and high diabetes prevalence[11]. Asia-Pacific shows rapid growth due to increasing diagnosis rates and healthcare investments[13].

Competitive Landscape

Key players include Zealand Pharma (Zegalogue), Novo Nordisk (GlucaGen), and Xeris Biopharma (Gvoke). Strategic moves include:

• Product Launches: Dasiglucagon (2021) for congenital hyperinsulinism[12].
• Partnerships: Collaboration between pharma firms and telehealth platforms to distribute emergency kits[14].

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Patent Landscape

Key Innovations

1. Glucagon Analogues (US10442847B2): Covers stable formulations (e.g., dasiglucagon) with extended shelf life in liquid form[7][12].
2. Dual Agonists (US9474780B2): Combines GLP-1 and GIP receptor activation, targeting both hypoglycemia and obesity[6].

Expiry and Impact

• US10442847B2 (Zealand Pharma) expires in 2034, protecting Zegalogue until then[12].
• Post-2030, generics may reduce prices by ~40%, but novel formulations (e.g., intranasal) will retain premium pricing[11][14].

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Regulatory and Trade Factors

• FDA/EMA Oversight: Strict manufacturing guidelines ensure safety but raise entry barriers for generics[11][14].
• Trade Dynamics: Export hubs like the U.S. and Switzerland dominate supply chains, with tariffs adding ~15% costs in emerging markets[11].

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Future Outlook

• Opportunities: Emerging markets (Latin America, Southeast Asia) offer untapped potential due to rising healthcare spending[13].
• Challenges: Regulatory complexity and cold-chain logistics for biologics hinder distribution in rural regions[14].

"The glucagon market’s evolution hinges on balancing innovation with accessibility, ensuring life-saving therapies reach all demographics." – Market.Us, 2024[13].

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FAQs

1. What is glucagon’s primary use?
   Treating severe hypoglycemia and aiding GI diagnostics[1][9].
2. Which companies lead glucagon production?
   Zealand Pharma, Novo Nordisk, and Amphastar Pharmaceuticals[11][14].
3. How do patents affect pricing?
   Exclusivity periods maintain high costs; generics post-expiry lower prices[12].
4. Which regions drive market growth?
   North America (established infrastructure) and Asia-Pacific (rising demand)[11][13].
5. What innovations are upcoming?
   Oral glucagon analogs and dual-hormone artificial pancreas systems[6][14].

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Citations: [1][6][7][9][11][12][13][14]

References

1. https://go.drugbank.com/drugs/DB00040
2. https://hsf.org.za/publications/special-publications/pharmaceuticals-in-south-africa/pharma-report-2018.pdf
3. https://vvkt.lrv.lt/media/viesa/saugykla/2023/9/09vLW9zMlcw.pdf
4. https://vvkt.lrv.lt/media/viesa/saugykla/2023/9/nvNsI8S7K9U.pdf
5. https://www.pharmacy.gov.my/v2/sites/default/files/document-upload/msom2008.pdf
6. https://patents.google.com/patent/US9474780B2/en
7. https://patents.google.com/patent/US10442847B2/en
8. https://www.pharmacompass.com/active-pharmaceutical-ingredients/glucagone
9. https://atcddd.fhi.no/atc_ddd_index/?code=H04A&showdescription=yes
10. https://www.youtube.com/watch?v=jg12jdPu-iA
11. https://market.us/report/glucagon-market/
12. https://www.drugpatentwatch.com/p/patent/10442847
13. https://www.pharmiweb.com/press-release/2024-05-07/glucagon-market-sees-surge-reaches-usd-11022-mn-value-by-2033
14. https://www.mordorintelligence.com/industry-reports/glucagon-market/market-size